Pharmaceutical Technology

MARCH 30, 2023

On March 29, the US Food and Drug Administration (FDA) granted approval for the first nonprescription, “over-the-counter” (OTC) naloxone nasal spray, Narcan. The overdose death rate in the US increased more than 250% from 1999 to 2019, as per a Canada-US joint white paper on substance use and harms.

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pharmaphorum

APRIL 21, 2021

Shares in Hikma have rallied as it resumed the launch of its generic Advair Diskus in the US, after clearing up a final piece of bureaucracy with the FDA. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

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The FDA Law Blog

FEBRUARY 16, 2023

Richardson — On February 15, 2023, the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) held a joint meeting to discuss an application pending before FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status.

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European Pharmaceutical Review

DECEMBER 13, 2022

The 1938 law effectively changed the focus of the Food and Drug Administration (FDA) from a policing agency to a regulatory agency tasked with overseeing the safety evaluation of new drug products. There is now global awareness of this issue and FDA issued a guidance note on the problem in 2007. Pharmacopoeia guidance on DEG and EG.

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European Pharmaceutical Review

SEPTEMBER 26, 2023

This recent decision by the EC follows approval of Tyruko ® (natalizumab) by the US Food and Drug Administration (FDA) last month for the same indication. Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019.

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Pharmaceutical Technology

MARCH 30, 2023

Earlier in March, the FDA shared a draft guidance on how to run clinical trials for the accelerated approval of cancer drugs. There, the FDA suggested that the drugs undergo randomised controlled trials, which the document describes as the preferred approach, rather than single-arm trials.

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Pharmaceutical Technology

JUNE 19, 2023

It is critical to understand the supply chain, plan your packaging, storage and distribution lanes, then test the entire process before patient shipments go live. Products are stored and packaged in a dedicated suite by a dedicated team,” explains MacNeir. The requirements When handling personalised medicines, time is of the essence.

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The FDA Law Blog

NOVEMBER 22, 2022

Reported illnesses began just three days before Thanksgiving in 2017, but due to the unknown source of the turkey at the center of the outbreak, the Centers for Disease Control and Prevention (CDC) did not conclude the outbreak investigation until April 2019. Two days before Thanksgiving the following year, the CDC warned U.S.

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European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. The payload is packaged inside a dissolvable needle, loaded within a microsyringe that is attached to a folded, self-inflating balloon. 2019 [cited 2023Feb]. the enteric coating and the capsule dissolve.

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pharmaphorum

AUGUST 16, 2021

In 2019, Formedix collaborated with a UK-based consortium interested in observing early safety data. These are now used by several regulatory bodies, including the Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for submission packages.

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The Checkup by Singlecare

OCTOBER 7, 2024

Januvia is FDA approved for people with Type 2 diabetes. For the most part, this means moderating your intake of cake and candy, sodas and fruit juices, and other pre-packaged treats, but not necessarily fruits that contain natural sugars, like bananas and grapes. Varughese, making Januvia less effective at stabilizing your glucose.

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ISPE

MARCH 8, 2023

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.

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Pharmacy Friday Pearls

SEPTEMBER 23, 2022

Four factor prothrombin complex concentrate (4F-PCC) is FDA approved to reverse vitamin K antagonists (VKAs) such as warfarin in adult patients with acute major bleeding or a need for an urgent surgery/invasive procedure. Dosing According to Package Insert. Kcentra (prothrombin complex concentrate [Human]) [package insert].

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pharmaphorum

JUNE 1, 2021

Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain. However, traceability and security measures focused on the packaging level may not be enough to protect patients.

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ISPE

MAY 11, 2023

The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. The goal is to break down complex processes into easy-to-grasp packages, including data privacy and information technology (IT) security. Pharmaceutical Engineering (May/June 2019). to Industry 4.0

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The Checkup by Singlecare

DECEMBER 26, 2023

A supplement package may claim it contains lion’s mane mushroom, but it may not specify what part of the mushroom it’s made from. Food and Drug Administration (FDA) does not regulate nutritional supplements in the same way that it regulates medications. Dr. Cooperman explains.

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ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). 2 October 2019. 11 September 2019. 6 November 2019. 12 July 2019.

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The Checkup by Singlecare

JULY 10, 2024

You’ve probably eaten seaweed as part of your favorite sushi dish before or even snacked on a package of dried seaweed from the shelf of your local health food store.

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The FDA Law Blog

SEPTEMBER 30, 2024

Penalties for “Misclassification” The Medicaid Services Investment and Accountability Act of 2019 added new penalties to the Medicaid rebate statute for knowingly misclassifying a covered outpatient drug. The most noteworthy are the following: 1. See 42 U.S.C. 1396r-8(b)(3)(C)(iii).

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

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ISPE

OCTOBER 27, 2022

Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. As a result, some companies have challenged the paradigm by forgoing lyophilization entirely, opting to provide solution phase API to drug product facilities for filling and packaging.

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PharmaShots

MARCH 9, 2023

She has also been awarded Crain’s Notable Women in Healthcare in 2019. Since its launch in 2016, Tivic Health has obtained three regulatory clearances for ClearUP, including FDA 510(k), FDA De Novo, and CE Mark, four patents, and numerous awards. She was also selected as the 39th Robert S.

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ISPE

MARCH 29, 2023

Published November 2019. As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

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ISPE

MARCH 29, 2023

Published November 2019. As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

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ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. It is considered a moderate change by the FDA (CBE30) and NMPA.

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ISPE

SEPTEMBER 11, 2023

m/s recommendation made its way into the US Food and Drug Administration (FDA)’s “Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice” 7 and into the EC GMP Annex 1 “Manufacture of Sterile Medicinal Products” in 2003. ASHRAE Journal (2019): 38–54. 5 , 6 From his research, the 0.45 At what velocity?

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The Thyroid Pharmacist

JULY 29, 2022

This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating. 2019 Apr 5;367:188-193. Published 2019 Sep 16. 2019 Apr 5;367:188-193.

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European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018. Edge Biologicals Inc.,

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The Checkup by Singlecare

OCTOBER 26, 2023

A 2019 study , for example, had participants take 20,000 IU of vitamin D weekly for 12 weeks, but no significant increase in testosterone levels was measured at the end of the study. Food and Drug Administration ( FDA ), so you may be taking a risk when you choose to add one to your diet.

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ISPE

JANUARY 10, 2023

The strategy is to provide an appropriate characterization package that demonstrates the alternative filter or resin will not impact product quality, submit it in a PAS, and, if needed, submit a request for an expedited review. This article presents a proposed regulatory strategy to help alleviate supply risks for approved therapeutics.

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The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. Follow package directions for each supplement. Sleep issues: I like to recommend Epsom salt baths, which contain magnesium that is absorbed through the skin (1 cup of salts per tub – follow package instructions, and don’t overdo it!), They’re great for injuries, overuse, or soreness from workouts.

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ISPE

JULY 6, 2023

Vertex continued to invest in CM with two additional approved drugs—Symdeco/Symkevi in 2018 and Trikafta in 2019—with the same indication. Table 1: List of FDA-approved commercial products using CM elements. Table 1: List of FDA-approved commercial products using CM elements. This is demonstrated by the rise from $1.05

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. This was higher than the number of approvals in 2019 and 2020. There are additional risks to consider with parenteral packaging.

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STAT

FEBRUARY 19, 2025

  One of Kennedy’s specific targets is the exemption that’s long allowed food manufacturers to introduce new additives without first receiving approval from FDA.   The GRAS rule has paved the way for thousands of ingredients never reviewed by the FDA to become embedded in the foods Americans eat.

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Pharmaceutical Technology

APRIL 21, 2023

The overdose US death rate that has seen a 250% increase from 1999 to 2019. On March 29, 2023, the US Food and Drug Administration (FDA) granted approval that made Narcan the opioid treatment drug to be sold without a prescription.

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European Pharmaceutical Review

APRIL 8, 2025

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. International Council for Harmonisation (ICH), 2019. International Council for Harmonisation (ICH), 2012.

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The FDA Law Blog

DECEMBER 11, 2024

Karst We learned earlier this week that an allision (a runner-up to Merriam-Websters 2024 Word of the Year, polarization) may be poised to occurperhaps within a fortnight (another runner-up to Merriam-Websters 2024 Word of the Year thanks to Taylor Swift)as Congress considers various pieces of healthcare legislation as part of its year-end package.

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